Company: Teva Pharmaceuticals Ltd
Qualifications:
B. Pharm/M. Pharm/ Master of Life Sciences – M Pharm preferred
Experience
Total years of experience required for the role: 2-4 years (preferred - Regulatory Publishing experience in EU and US market)
Freshers can also be considered
Function
Job Description
- Publish and dispatch major and complex routine/lifecycle management eCTD submission projects for EU, US and Canada.
- Exposure in handling initial submissions publishing and transmitting quality submissions to agency.
- Perform document level publishing activities, troubleshoot document issues and perform quality control checks for submission ready documents as per the agency guidance.
- Collaborate with scientific personnel for planning, preparation, publishing and quality control checks of submissions.
- Hands-on expertise in EU and US submissions from pre-approval to post approval activities like initial, variations, PSUR etc.
- Participate in Global Regulatory Affairs project.
- Maintain working knowledge of internal and external publishing standards.
- Knowledge of ICH and eCTD related specification/guidelines governing regulatory submissions (eCTD, NeeS, paper)
- Must be aware of Technical systems like Global Insight, ISI Toolbox, Adobe Acrobat, Lorenz Validator
- Sees opportunities for creative problem solving while staying within the parameters of good practice. Generates unique but workable and useful solutions to difficult problems
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